Different minimally important clinical difference (MCID) scores lead to different clinical prediction rules for the Oswestry disability index for the same sample of patients.
ABSTRACT: Minimal clinically important difference (MCID) scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. There are numerous outcome instruments used for analyzing pain, disability, and dysfunction of the low back; perhaps the most common of these is the Oswestry disability index (ODI). A single agreed-upon MCID score for the ODI has yet to be established. What is also unknown is whether selected baseline variables will be universal predictors regardless of the MCID used for a particular outcome measure.To explore the relationship between predictive models and the MCID cutpoint on the ODI.Data were collected from 16 outpatient physical therapy clinics in 10 states.Secondary database analysis using backward stepwise deletion logistic regression of data from a randomized controlled trial (RCT) to create prognostic clinical prediction rules (CPR).One hundred and forty-nine patients with low back pain (LBP) were enrolled in the RCT. All were treated with manual therapy, with a majority also receiving spine-strengthening exercises.The resultant predictive models were dependent upon the MCID used and baseline sample characteristics. All CPR were statistically significant (P < 001). All six MCID cutpoints used resulted in completely different significant predictor variables with no predictor significant across all models.The primary limitations include sub-optimal sample size and study design.There is extreme variability among predictive models created using different MCIDs on the ODI within the same patient population. Our findings highlight the instability of predictive modeling, as these models are significantly affected by population baseline characteristics along with the MCID used. Clinicians must be aware of the fragility of CPR prior to applying each in clinical practice.
Project description:PURPOSE: The Oswestry Disability Index (ODI) is one of the most common scoring systems used for patients with low back pain (LBP). Although the normative score of the ODI was reported to be 10.19 in a review article, no study has calculated the normative score after adjusting the value based on the age distribution. In addition, none of the previous studies has estimated the cut-off value which separates LBP with disability from LBP without disability. The purpose of this study was to estimate the normative score by adjusting the data for age distribution in Japan, and to determine the cut-off value which separates LBP with disability from LBP without disability. METHODS: We conducted an internet survey on LBP using the Japanese version of the ODQ. A total of 1,200 respondents, composed of 100 males and 100 females in each age group (from the 20s to 70s), participated in this study. We also asked them to provide information about their backgrounds. We estimated the normative score after correcting for the age distribution of Japan. We also estimated the ODI of those with or without disability, the factors associated with the ODI, and the cut-off value which separates LBP with disability from LBP without disability. RESULTS: The participants' backgrounds were similar to the national survey. The normative score of the ODI was estimated at 8.73. The ODI of the LBP with disability group was 22.07. Those with sciatica and obese subjects showed higher ODI than those without. The optimal cut-off value was estimated to be 12. CONCLUSIONS: We defined the normative score and the cut-off value of the ODI.
Project description:INTRODUCTION:Low-Back Pain (LBP) is a common public health problem that is often worsened by maladaptive beliefs and disability. Thus, necessitating the need for availability of outcome measures to assess these sequelae among patients with chronic LBP. This study aimed to cross-culturally adapt and determine the psychometric properties of the Yoruba version of the ODI (ODI-Y). METHODS:The ODI-Y was cross-culturally adapted following the process involving forward translation, synthesis, backward translation, expert review, and pilot testing. Internal consistency and test-retest reliability of the ODI-Y were determined using the Cronbach's alpha and intra-class correlation. Other psychometric properties explored included the factor structure, convergent validity, standard error of measurement and the minimal detectable change. RESULTS:One hundred and thirty-six patients with chronic LBP took part in the validation of the ODI-Y; 86 of these individuals took part in the test-retest reliability (within 1-week interval) of the translated instrument. The mean age of the respondents was 50.5±10.6years. The ODI-Y showed a high internal consistency, with a Cronbach's alpha (?) of 0.81. Test-retest of the Yoruba version of the ODI within 1-week interval yielded an Intra-Class Correlation coefficient of 0.89. The ODI-Y yielded a three-factor structure which accounted for 61.56% of the variance. Correlation of ODI-Y with the visual analogue scale was moderate (r = 0.30; p = 0.001). The standard error of measurement and minimal detectable change of the ODI-Y were 2.0 and 5.5. CONCLUSIONS:The ODI was adapted into the Yoruba language and proved to have good psychometric properties that replicated the results of other obtainable versions. We recommend it for use among Yoruba speaking patients with LBP.
Project description:Study Design:Prospective multicenter cohort study. Objective:To investigate (1) the discriminative ability and cutoff estimates for success 12 months after surgery for lumbar disc herniation on the Oswestry Disability Index (ODI) raw score compared with a change and a percentage change score and (2) to what extent these clinical outcomes depend on the baseline disability. Methods:A total of 6840 patients operated for lumbar disc herniation from the Norwegian Registry for Spine Surgery (NORspine) were included. In receiver operating characteristic (ROC) curve analyses, a global perceived effect (GPE) scale (1-7) was used an external anchor. Success was defined as categories 1-2, "completely recovered" and "much better." Cutoffs for success for subgroups with different preoperative disability were also estimated. Results:When defining success after surgery for lumbar disc herniation, the accuracy (sensitivity, specificity, area under the curve, 95% CI) for the ODI raw score (0.83, 0.87, 0.930, 0.924-0.937) was comparable to the ODI percentage change score (0.85, 0.85, 0.925, 0.918-0.931), and higher than the ODI change score (0.79, 0.73, 0.838, 0.830-0.852). The cutoff for success was highly dependent on the amount of baseline disability (low-high), with cutoffs ranging from 13 to 28 for the ODI raw score and 39% to 66% for ODI percentage change. The ODI change score (points) was not as accurate. Conclusion:The 12-month ODI raw score, like the ODI percentage change score, can define a successful outcome with excellent accuracy. Adjustment for the baseline ODI score should be performed when comparing outcomes across groups, and one should consider using cutoffs according to preoperative disability (low, medium, high ODI scores).
Project description:PURPOSE: Patient-reported outcome measurements (PROMs) are widely used in spine care. The development of reliable and valid National versions of spine-related disability questionnaires is strongly recommended from both the clinical and scientific points-of-view. The aims of this study were to adapt and validate the Oswestry Disability Index (ODI) and the Quebec back pain disability scale (QDS) for use with the Hungarian language. METHODS: After translating and culturally adapting the ODI and QDS, 133 patients with lumbar degenerative spinal disorder filled in the questionnaire booklet twice within 2 weeks. Subjects completed the Hungarian versions of the two PROMs as well as the WHOQoL-BREF validated as a general life quality questionnaire and Visual Analogue Scale of pain. Internal consistency, reliability and construct validity of the questionnaires were determined, as were the standard error of measurement (SEM) and minimal detectable change (MDC) scores. RESULTS: The Hungarian ODI consisted of one factor that showed good internal consistency (Cronbach-? 0.890). The QDS showed a four-factor structure with Cronbach-? values between 0.788 and 0.917. No significant floor or ceiling effects were observed. The test-retest analysis showed excellent reliability of the Hungarian ODI and QDS. The intraclass correlation coefficients (ICC) were 0.927 and 0.923, respectively. SEM values of 4.8 and 5.2 resulted in a MDC of 13 and 14 points in the Hungarian ODI and QDS, respectively. The correlation coefficient (r) between pain and ODI was 0.680 (p < 0.001) and the correlation between the ODI and the physical subscale of WHOQoL was also very good (r = -0.705, p < 0.001). The QDS total score and its four subscales correlated significantly with pain and with the physical subscale of WHOQoL (r > 0.4, p < 0.001). The level of disability measured by the Hungarian ODI and QDS was significantly higher in the surgical subgroup than in non-surgically treated patients (p < 0.001). CONCLUSIONS: Translation and cultural adaptation of the ODI and QDS were successful. Hungarian versions of the ODI and QDS proved to be reliable, valid PROMs confirming that they can be used in future clinical and scientific work with Hungarian-speaking spine patients.
Project description:STUDY DESIGN: Prospective cohort study along with questionnaire. PURPOSE: To measure the correlation of the visual analogue score (VAS), with (Oswestry disability Index [ODI], version 2.1a) in English, and modified ODI (English and Hindi version). To validate translated version of the modified ODI in English version to Hindi. OVERVIEW OF LITERATURE: Conflicting evidence in literature regarding the ability for existing ODI score to accurately measure the pain associated disability. METHODS: One hundred and three patients conservatively treated for low back pain were enrolled in the study. The Pearson correlation coefficient for VAS and ODI along with the Cronbach ? and test-retest reliability for Hindi version using the intraclass correlation coefficient was recorded. The new proposed translated Hindi version of ODI was carried out with established guidelines. RESULTS: The mean age in English and Hindi version of ODI was 53.5 years and 58.5 years, respectively. The gender ration was 21:24 in the English version and 35:23 in the Hindi version. The mean follow-up in English and Hindi version of ODI was 3.4 months and 50.27 months, respectively. The Cronbach coefficient ?=0.7541 for English ODI and 0.9913 for Hindi ODI was recorded for the both modified versions. CONCLUSIONS: The new modified ODI is time saving and accurate, and it avoids the need to measure other scores and has stronger correlation with VAS score compared to the previous scores. We recommend this version for both English and Hindi speaking population as an assessment tool to measure the disability related to pain.
Project description:OBJECTIVES:The purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS). MATERIALS AND METHODS:Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10-Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ?2-point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ-5D). RESULTS:For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ?MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ?MCID improvement in ODI was 52%, 57%, and 60% while those with ?MCID improvement in EQ-5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach. CONCLUSIONS:Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.
Project description:BACKGROUND:Cardiac arrest is still a global public health problem at present. The neurological outcome is the core indicator of the prognosis of cardiac arrest. However, there is no effective means or tools to predict the neurological outcome of patients with coma and survived 24?hours after successful cardiopulmonary resuscitation (CPR). HYPOTHESIS:Therefore, we expect to construct a prediction model to predict the neurological outcome for patients with coma and survived 24 hours after successful CPR. METHODS:A retrospective cohort study was used to construct a prediction model of the neurological function for patients with coma and survived 24?hours after successful CPR. From January 2007 to December 2015, a total of 262 patients met the inclusion and exclusion criteria. RESULTS:The predictive model was developed using preselected variables by a systematic review of the literature. Finally, we get five sets of models (three sets of construction models and two sets of internal verification models) which with similar predictive value. The stepwise model, which including seven variables (age, noncardiac etiology, nonshockable rhythm, bystander CPR, total epinephrine dose, APTT, and SOFA score), was the simplest model, so we choose it as our final predictive model. The area under the ROC curve (AUC), specificity, and sensitivity of the stepwise model were respectively 0.82 (0.77, 0.87), 0.72and 0.82. The AUC, specificity, and sensitivity of the bootstrap stepwise (BS stepwise) model were respectively 0.82 (0.77, 0.87), 0.71, and 0.82. CONCLUSION:This new and validated predictive model may provide individualized estimates of neurological function for patients with coma and survived 24?hours after successful CPR using readily obtained clinical risk factors. External validation studies are required further to demonstrate the model's accuracy in diverse patient populations.
Project description:The need for cost effectiveness analyses in randomized controlled trials that compare treatment options is increasing. The selection of the optimal utility measure is important, and a central question is whether the two most commonly used indexes - the EuroQuol 5D (EQ5D) and the Short Form 6D (SF6D) - can be used interchangeably. The aim of the present study was to compare change scores of the EQ5D and SF6D utility indexes in terms of some important measurement properties. The psychometric properties of the two utility indexes were compared to a disease-specific instrument, the Oswestry Disability Index (ODI), in the setting of a randomized controlled trial for degenerative disc disease.In a randomized controlled multicentre trial, 172 patients who had experienced low back pain for an average of 6 years were randomized to either treatment with an intensive back rehabilitation program or surgery to insert disc prostheses. Patients filled out the ODI, EQ5D, and SF-36 at baseline and two-year follow up. The utility indexes was compared with respect to measurement error, structural validity, criterion validity, responsiveness, and interpretability according to the COSMIN taxonomy.At follow up, 113 patients had change score values for all three instruments. The SF6D had better similarity with the disease-specific instrument (ODI) regarding sensitivity, specificity, and responsiveness. Measurement error was lower for the SF6D (0.056) compared to the EQ5D (0.155). The minimal important change score value was 0.031 for SF6D and 0.173 for EQ5D. The minimal detectable change score value at a 95% confidence level were 0.157 for SF6D and 0.429 for EQ5D, and the difference in mean change score values (SD) between them was 0.23 (0.29) and so exceeded the clinical significant change score value for both instruments. Analysis of psychometric properties indicated that the indexes are unidimensional when considered separately, but that they do not exactly measure the same underlying construct.This study indicates that the difference in important measurement properties between EQ5D and SF6D is too large to consider them interchangeable. Since the similarity with the "gold standard" (the disease-specific instrument) was quite different, this could indicate that the choice of index should be determined by the diagnosis.
Project description:BACKGROUND: The sacro-iliac joint (SIJ) is the largest joint in the human body. When the lumbar spine is fused to the sacrum, motion across the SIJ is increased, leading to increased degeneration of the SIJ. Degeneration can become symptomatic in up to 75% of the cases when a long lumbar fusion ends with a sacral fixation. If medical treatments fail, patients can undergo surgical fixation of the SIJ. QUESTIONS/PURPOSES: This study reports the results of short-term complications, length of stay, and clinical as well as radiographic outcomes of patients undergoing percutaneous SIJ fixation for SIJ pain following long fusions to the sacrum for adult scoliosis. METHODS: A retrospective review of all the patients who underwent a percutaneous fixation of the SIJ after corrective scoliosis surgery was performed in a single specialized scoliosis center between the years 2011-2013. Ten SIJ fusions were performed in six patients who failed conservative care for SIJ arthritis. Average age was 50 (range 25-60 years). The patients were 15.3 years in average after the original surgical procedure (range 4-25 years). Average post-operative follow-up was 10.25 months (range 15-4 months). The medical charts of the patients were reviewed for hospital stay, complications, pre- and post-operative pain, quality of life, and satisfaction with surgery using the visual analogues score (VAS), Scoliosis Research Society (SRS)22 and Oswestry Disability Index (ODI) questionnaires. Images were reviewed for fixation of the SIJ, fusion, and deviation of the implants from the SIJ. RESULTS: There were no complications in surgery or post-operatively. Discharge was on post-operative day 2 (range 1-4 days). Leg VAS score improved from 6.5 to 2.0 (P?<?0.005; minimal clinically important difference (MCID) 1.6). Back VAS score decreased from 7.83 to 2.67 mm (P?<?0.005; MCID 1.2). ODI scores dropped from 22.2 to 10.5 (P?=?0.0005; MCID 12.4). SRS22 scores increased from 2.93 to 3.65 (P?=?0.035; MCID 0.2) with the largest increases in the pain, function, and satisfaction domains of the questionnaires. CONCLUSION: Fixation of the SIJ in patients that fail conservative care for SIJ arthritis after long fusions ending in the sacrum provides a reduction in back pain and improved quality of life in the short and medium range follow-up period.
Project description:Background: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear. Methods: Lumbar discectomy patients with an annular defect ?6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (?60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results. Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries. Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients.